March 26, 2014
Michelson Diagnostics, the UK based medical device company focused on multi-beam Optical Coherence Tomography (‘OCT’) technology, announces positive top line results from the successfully completed multi-centre, prospective clinical trial for the diagnosis of basal cell carcinoma using VivoSight OCT.
In the study, over 250 patients with clinically suspicious lesions for basal cell carcinoma were scanned at six centres in Germany. In each case, diagnosis using VivoSight OCT was compared with standard clinical diagnosis with and without dermoscopy. All results were verified by the gold standard of biopsy and histological analysis.
Papers by Professor Dr. med. Julia Welzel, Dr. med. Martina Ulrich discussing the results from the clinical study were presented at the American Academy of Dermatology’s 72nd Annual Meeting (AAD) in Denver, Colorado, on Tuesday, 25 March 2014.
Dr Ulrich concluded in her presentation that: “VivoSight enabled a statistically significant improvement in the specificity and Negative Predictive Value (NPV) of Basal Cell Carcinoma diagnosis over both clinical and dermoscopy on this cohort of challenging pink patches. So many biopsies can be rendered unnecessary, with VivoSight OCT, patients can instead be treated non-invasively.”
Dr Gordon McKenzie, Director of Clinical Development at Michelson Diagnostics, said: “We are delighted that Dr Ulrich and her colleagues were able to present these exciting results with such clear implications for clinical practice in terms of the avoidance of biopsy in many situations.”
Jon Holmes, CEO of Michelson Diagnostics, added: “The positive results from our study clearly demonstrate the clinical benefits of using our VivoSight OCT system in the diagnosis and monitoring of basal cell carcinoma. We believe that VivoSight has the potential to become the standard of care for the non-invasive diagnosis and monitoring of certain diseases and conditions that affect the skin, and in particular non-melanoma skin cancers. We look forward to releasing the full data in due course.”
The full results will be published in a leading peer review journal later this year.
See the press release here.